Comparative Efficacy of the Suppository Versus Guaiacol Suppository Versus Guaifenesin Syrup in Pediatric Patients With Cough Due the Infectious Origin

Comparative Efficacy of the Suppository Composed by Guaiacol, Eucalyptol, Menthol and Camphor Versus Guaiacol Suppository Versus Guaifenesin Syrup in Pediatric Patients With Cough Due the Infectious Origin

It is believed that the suppository consisting of guaiacol, menthol, camphor and eucalyptol, by their pharmacological properties already established for each component, has the ability to reduce the signs and symptoms related to upper respiratory infections in a manner equivalent (not inferior) to medicine used as a comparator in this study and higher than the suppository containing only guaiacol concentration of 12.5 mg.

Study Overview

• Status: Unknown
• Conditions: Cough
• Intervention / Treatment: Drug: Guaiacol, eucalyptol, menthol and camphor suppository; Drug: guaiacol suppository; Drug: Guaifenesin syrup

• Study Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Valinhos, SP, Brazil, 13270000
      • LAL Clínica Pesquisa e Desenvolvimento Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients that parents or legal guardians agree to their participation in the study and agree on the terms proposed in the IC, signing it;
• Patients aged ≥ (greater than or equal to) 02 years and ≤ (less than or equal to) 6 years, 11 months and 29 days, of any ethnicity, class or social group.
• Patients with acute respiratory disease of upper respiratory viral diseases (URI);
• Patients with productive cough;
• Clinical picture of URI defined by the doctor that started less than 48 hours.

Exclusion Criteria:

• Patients being treated with antibiotics;
• Presence of clinical features of bacterial infection of the upper airways and / or pulmonary (acute bacterial sinusitis, pneumonia, etc.).
• Patients with non-productive cough;
• Treatment with immunosuppressive drugs;
• Presence of any medical condition that, according to the investigator, should prevent the patient from the study;
• Participation in clinical trials in the 12 months preceding the study, according to Resolution 251 (ANVISA), August 7, 1997, item III, sub-item J;
• Patients with serious diseases;
• Patients who require multidrug treatment;
• Presence of other concomitant pulmonary diseases
• History of hypersensitivity to drugs of the same pharmacological classes of substances under investigation;
• Patients with diseases that interfere with lung function, such as cerebral palsy or muscular atrophies;
• Patients under medication or supplement (eg physiotherapy) that may interfere with the cough;
• Patients with severe dysfunction of the hepatorenal function;
• Patients with x-ray of the chest or sinus compatible with picture of bacterial infection;
• Patients with blood cell count suggestive of bacterial infection;
• Changes in laboratory, clinical, physical and / or radiological agents that, judged by investigators, could compromise patient health or reliability of the data.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transpulmin; Suppository composed by guaiacol, eucalyptol, menthol and camphor	Drug: Guaiacol, eucalyptol, menthol and camphor suppository; 2 times per day
Active Comparator: Comparator 1; Suppository composed by guaiacol	Drug: guaiacol suppository; 2 times per day
Active Comparator: Comparator 2; Syrup composed by guaifenesin	Drug: Guaifenesin syrup; 4.19 mL - 4 in 4 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of cough of infectious origin.	During visits (V1, V2, V3 and V4) will be assessed the signs of improvement of cough of infectious origin.	7 days of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of parameters for the improvement of infectious cough.	During visits (V1, V2, V3 and V4) will be assessed the signs of improvement in difficulty in breathing,quality of sleep,nasal obstruction, food intake and adherence to the treatment.	7 days of treatment.

Collaborators and Investigators

• Sponsor: Azidus Brasil

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: April 29, 2010
• First Submitted That Met QC Criteria: May 6, 2010
• First Posted (Estimate): May 7, 2010

Study Record Updates

• Last Update Posted (Estimate): January 28, 2011
• Last Update Submitted That Met QC Criteria: January 27, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Cough treatment
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Dermatologic Agents; Respiratory System Agents; Appetite Depressants; Anti-Obesity Agents; Antipruritics; Antitussive Agents; Sympathomimetics; Expectorants; Vasoconstrictor Agents; Nasal Decongestants; Insect Repellents; Menthol; Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination; Eucalyptol; Camphor
• Other Study ID Numbers: ACH-TRN-03(01/10); Version 05 - March 9, 2010